Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder

Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week
open-label treatment period with F2695 SR are randomized to continue F2695 SR or switch to
placebo under double-blind conditions for up to 24 weeks of additional treatment.

Inclusion Criteria:

- Men and women, 18-65 years old

- Currently meet the DSM-IV-TR criteria for Major Depressive Disorder

- The patient's current depressive episode must be at least 4 weeks in duration

Exclusion Criteria:

- Women who are pregnant, women who will be breastfeeding during the study, and women
with childbearing potential who are not practicing a reliable method of birth control

- Patients with a history of meeting DSM-IV-TR criteria for:

- any manic or hypomanic episode

- schizophrenia or any other psychotic disorder

- obsessive-compulsive disorder

- Patients who are considered a suicide risk